BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD,FIXATION,INTRAMEDULLARY

    MDR report key: 5402240 · Received February 1, 2016

    Report

    Report Number
    2520274-2016-10476
    Event Type
    Injury
    Date Received
    February 1, 2016
    Report Date
    January 14, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. UENO, MASAKI, ET AL, (2006) EARLY UNREAMED INTRAMEDULLARY NAILING WITHOUT A SAFETY INTERVAL AND SIMULTANEOUS FLAP COVERAGE FOLLOWING EXTERNAL FIXATION IN TYPE IIIB OPEN TIBIAL FRACTURES: A REPORT OF FOUR SUCCESSFUL CASES. INJURY, INT. J. CARE INJURED 37, 289-294. JAPAN THIS REPORT IS FOR AN AO SOLID TIBIAL NAIL, UNKNOWN QUANTITY, UNKNOWN LOT. PATIENT EXPERIENCED HYPERTROPHIC NONUNION. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING LITERATURE ARTICLE: EARLY UNREAMED INTRAMEDULLARY NAILING WITHOUT A SAFETY INTERVAL AND SIMULTANEOUS FLAP COVERAGE FOLLOWING EXTERNAL FIXATION IN TYPE IIIB OPEN TIBIAL FRACTURES: A REPORT OF FOUR SUCCESSFUL CASES. INJURY, INT. J. CARE INJURED (2006) 37, 289-294. JAPAN THIS ARTICLE DISCUSSES 4 CONSECUTIVE CASES OF TYPE IIIB OPEN TIBIAL FRACTURES, WHICH WERE SUCCESSFULLY MANAGED WITH EARLY UNREAMED INTRAMEDULLARY NAILING (IMN) AND SIMULTANEOUS FLAP COVERAGE WITHOUT A SAFETY INTERVAL FOLLOWING EXTERNAL FIXATION (EF). THE PARTICIPANTS INCLUDED A (B)(6) FEMALE INVOLVED IN A MOTORCYCLE INJURY. THE REST WERE ALL MALES AGED 23, 28, AND 60 YEARS, RESPECTIVELY, WHO INJURED THEIR LOWER LEGS DURING A TRAFFIC ACCIDENT. THIS REPORT IS 1 OF 2 FOR (B)(4). THIS REPORT IS FOR AN AO SOLID TIBIAL NAIL, INVOLVING A (B)(6) FEMALE PATIENT. THE PATIENT EXPERIENCED HYPERTROPHIC NONUNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59657 ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention